[Congressional Record (Bound Edition), Volume 155 (2009), Part 13]
[Senate]
[Pages 17369-17370]
[From the U.S. Government Publishing Office, www.gpo.gov]




                               BIOLOGICS

  Mr. BROWN. Mr. President, this week Congress is deciding whether to 
broaden access to affordable generic drugs for millions of Americans. 
As we all argue our points, it is important to remember what this issue 
is all about. Broadening access to generic drugs is not about 
Republicans or Democrats. It is not even about the drug companies, the 
biologic makers, or the other pharmaceutical companies. It is about men 
and women in my State and the State of the Presiding Officer and around 
the country. Broadening access to generic drugs is about the 192,370 
new cases of breast cancer that will be diagnosed in American women 
this year, and the $48,000 average annually is what it will cost to 
treat their disease with the biologic drug Herceptin, $48,000 annually. 
This is about the 1.3 million adults affected by rheumatoid arthritis 
each year and the $2,000 average annually it cost to treat their 
difficult disease with the biologic drug Remicade. Broadening access to 
generics is about the 148,610 men and women diagnosed with colon cancer 
each year and the $100,000 it costs them each year to treat the disease 
with the biologic drug Avastin.
  Let me mention a few other noteworthy numbers: $1.2 billion 
represents the average cost to develop a new biotech product; this 
includes research and development and the costs lost to products that 
never make it to market. It is not just $1.2 billion for the product 
itself that makes it to market. It is about the false starts and 
includes all that too. Continuing, $9.2 billion represents the 2008 
sales of Genentech's biologic colon cancer treatment Avastin. I said it 
cost $100,000 per patient to treat with that drug. Eight billion 
represents the 2008 sales of Amgen's biologic arthritis treatment 
Enbrel. Finally, $7 million represents how much money PhRMA spent in 
the first 3 months of 2009 to lobby Congress; $7 million to lobby 
Congress in the first 3 months of this year. That is before we started 
the most intense part of working on this bill.
  I encourage colleagues on both sides of the aisle to keep all of 
these numbers in mind as we go through the debate this week and next 
week--the numbers of patients who depend on these drugs, the cost to 
the patients one by one by one for each of these drugs, the amount of 
money the drug companies, the biologic companies have made on these 
drugs, and the amount of money they are spending lobbying Congress to 
have their way on these issues.
  Countless Americans cannot afford expensive brandname drugs, known as 
biologics. These drugs provide promise and hope--and we are very 
indebted to these companies for developing these drugs; they clearly 
save lives--these drugs provide promise and hope to those suffering 
from devastating diseases and chronic illnesses, including cancer, 
Parkinson's, diabetes, Alzheimer's, and MS.
  For example, annual treatment for breast cancer with the biologic 
drug Herceptin costs $48,000 a year. The annual treatment for 
rheumatoid arthritis with Remicade, as I said, costs approximately 
$20,000 a year. These drugs are simply too expensive for so many people 
to afford.
  The average household income in Ohio for 2007 was $46,597. For the 
patient who cannot afford a treatment, it does not matter if it is a 
breakthrough and it does not matter if it is lifesaving, he or she 
simply cannot afford it.
  There is currently--to put this in context--no FDA approval process 
for biogenerics, biologic generic equivalents, comparable to the 
process that enables generic drugs to compete against their brandname 
counterparts.
  We all have seen the money you can save when you go to your doctor 
for a typical drug that has a generic substitute. It is the same drug 
with the same active ingredients, and a physician will encourage their 
patient to buy the generic equivalent. That is true for the chemical 
drugs we have had for many years. It is not true for the biologics. 
There is no generic equivalent. There is no pathway allowed for 
generics to compete against the biologics.
  Absent that process, there is no free market exerting downward 
pressure on biologic prices, so prices remain high, so prices remain 
$20,000 a year or sometimes as high as $7,000 or $8,000 a month for 
some of these biologics.
  That is the problem in a nutshell, but behind it--this is all talking 
public policy up here--but behind it, underneath it, are the lives of 
hundreds of thousands of Americans, situations in which Americans 
cannot afford treatments that prevent disability and, in some cases, 
prevent death.
  Early this year, Ohio representatives from the Arthritis Foundation 
visited my office to talk about soaring health care costs and the 
limitations of our current system. These individuals spoke of extreme 
and prolonged physical pain, pain that could be alleviated if only the 
treatments existed--which they do--and only if they were affordable--
which too often they are not.
  Biologics provide great promise and hope to those suffering from 
devastating diseases and chronic illnesses. But absent competition, 
absent what we call follow-on biologics, absent a generic substitute to 
compete--but absent competition--countless Americans will be unable to 
benefit from these medicines.
  It would be irresponsible on our part not to pursue a safe and 
efficient path to biogenerics. And it would be irresponsible on our 
part to pursue a pathway that allows for over a decade of

[[Page 17370]]

monopoly protections for brandname products.
  We did not do that with the generic drugs, the so-called Hatch-Waxman 
bill, which everyone in this body is familiar with. Most people at home 
around our country--most people in Toledo and Akron and Cincinnati and 
Dayton and Springfield and Mansfield--have benefited from Hatch-Waxman, 
the generic drug law, which cut prices for brandname drugs 50, 60, 70, 
80 percent. But you cannot do that with biologics because we have not 
written the law to open up the process to allow follow-on biologics, to 
allow generic biologics, to allow competition in the system.
  But next week, as the Presiding Officer knows, in the Health, 
Education, Labor and Pensions Committee, we have the opportunity to 
make affordable generic drugs more accessible for our seniors, more 
accessible for our Nation's middle class, more accessible for the 
hundreds of thousands--no, the millions--of Americans who are suffering 
from these diseases. But so many of them are unable to afford these 
expensive biologics.
  Health care reform must broaden access to generic alternatives to 
biologics, the most expensive kinds of prescription drugs. Failing to 
do so is not just bad policy, bad public policy; failing to do so means 
we are letting down millions of our sickest citizens.
  Mr. President, I yield the floor and suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. REID. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.

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